TX2® Low Profile TAA Endovascular Graft (TX2® LP)

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The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

Condition or disease

Intervention/treatment

Aortic AneurysmPenetrating UlcerVascular Disease

Device: Zenith® TX2® Low Profile TAA Endovascular Graft

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Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Descending thoracic aneurysm with diameter ≥ 5.0 cm

Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year